Biodesign Recto-Vaginal Fistula Plug expires before labeled expiration date
Cook Biotech is recalling 3 units of Biodesign Recto-Vaginal Fistula Plug RVP-0.2 because the devices expire prior to the expiration date printed on the labeling.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a risk-of-harm surgical implant where premature expiration may compromise sterility assurance. No injuries or illnesses have been reported. Per the rubric, risk-of-harm products without reported injury score as High (3).
Plain-English summary
Cook Biotech, Inc. is recalling 3 units of the Biodesign Recto-Vaginal Fistula Plug RVP-0.2 (Order Number G46601, Lot LB1534431). This surgical implant is designed for implantation to reinforce soft tissue for the repair of recto-vaginal fistulas.
The recall was initiated because the products expire prior to the expiration date printed on the product labeling. This means the devices may not meet their sterility and safety specifications before the labeled expiration date.
Distribution was worldwide, including the United States and the following countries: Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, South Africa, and the United Kingdom.
Patients and healthcare providers who have received or used these devices should contact Cook Biotech, Inc. for guidance regarding replacement or management options.
The recalled product
- Product
- Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46601
- Manufacturer
- Cook Biotech, Inc.
- Hazard
- premature-expiration
- sterility-compromise
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: (01)00827002466012(17)250603(10)LB1534431 Lot Number: LB1534431
Distribution
Distributed nationwide across the United States.
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